Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions

Not Applicable

Completed

• Conditions: Feeding Disorder of Infancy or Early Childhood
• Interventions: Behavioral: Mealtime PREP (Promoting Routines of Exploration and Play)

• Registration Number: NCT03138551
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.

Detailed Description

This pilot study will collect rich data from twenty participants on the feasibility and effects of a novel intervention, the Mealtime PREP, which has a dyadic focus on both the young child and the parent participants. The investigators will collect video recorded child meals in the home during a baseline period (under normal circumstances), during parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn). This in depth examination of child meals will provide valuable information to guide the optimization of this intervention approach for future trials.

Study Timeline

• Study Start: 2015-10-11
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-03
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Child must meet all criteria of the diagnosis of Sensory Food Aversions

  1. The child consistently refuses to eat specific foods with specific tastes/textures and/or smells.
  2. Onset of food refusal occurs during the introduction of a novel type of food (e.g., the child may drink one type of milk but refuse another, may eat carrots but refuse green beans, may drink milk but refuse baby food).
  3. The child eats without difficulty when offered preferred foods.
  4. The food refusal causes specific nutritional deficiencies or delay of oral motor development.

• Parent is able to read, write, speak and understand English.

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mealtime PREP	Mealtime PREP (Promoting Routines of Exploration and Play)	Every participant enrolled in this single-case experimental design trial with multiple replications progressed through three phases. A: Baseline - typical mealtimes in the home. B: Parent-Training - parents trained in Mealtime PREP (Promoting Routines of Exploration and Play) intervention. B-prime: Family Autonomy - parents continue to deliver treatment strategies. Therapist support withdrawn.

Primary Outcome Measures

Name	Time	Method
Food Acceptance	30 meals video recorded throughout study participation (10 per phase, 1 month)	Significant change in percentage of targeted food accepted between phases.

Secondary Outcome Measures

Name	Time	Method
Behavioral Pediatric Feeding Assessment (BPFAS)	Baseline through Study Completion (1 month)	Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.
3-Day Food Diary	Baseline through Study Completion (1 month)	Increased number of foods eaten over a three-day period.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States